Mfg Scientist I/Sr Engineer I, Cell Banking – Mfg Sciences
Posted on: 12 Feb 2021
Research Triangle Park, NC
Job Description
Job Description
The Mfg Scientist I/ Sr Engineer I, Manufacturing Sciences will provide support within the Manufacturing Sciences (MS) Cell Banking group. As appropriate, responsibilities include:
* Author and support regulatory filings, relevant to cell banking operations
* Assist with external cell banking technology transfers, specific to Gene Therapy
* Develop workflows for management of Gene Therapy cell banks and viral stocks
* Provide subject matter expert guidance relevant to cell banking during internal, partner and agency inspections
* Execute cell bank growth characterization and stability laboratory experiments
* Author cell bank manufacturing, growth characterization and stability technical reports
* Provide technical support and assessments for cell bank deviations
Qualifications
* Technical understanding of mammalian cell culture appropriate to cell banking operations
* Excellent organizational, attention to detail, verbal and written communication skills
* Ability to work independently and complete projects in an efficient and timely manner
* Comfortable analyzing scientific datasets
* Experience with change controls and electronic document management systems
Education:
* Bachelors with 6 8 years of experience in chemical engineering, biochemistry, biology or similar or
* Masters with 4-6 years of experience in chemical engineering, biochemistry, biology or similar or
* PhD with 0-2 years of experience in chemical engineering, biochemistry, biology or similar
Additional Information
The Mfg Scientist I/Sr Engineer, Cell Banking Manufacturing Sciences, will provide technical expertise for the internal and external manufacture of cell banks.
Biogen
Cambridge, MA
Biogen Inc. discovers, develops, manufactures, and delivers therapies for treating neurological and neurodegenerative diseases worldwide. The company offers TECFIDERA, AVONEX, PLEGRIDY, TYSABRI, and FAMPYRA for the treatment of multiple sclerosis (MS); SPINRAZA for the treatment of spinal muscular atrophy; and FUMADERM for the treatment of plaque psoriasis. It also provides BENEPALI, an etanercept biosimilar referencing ENBREL; FLIXABI, an infliximab biosimilar referencing REMICADE; and IMRALDI, an adalimumab biosimilar referencing HUMIRA. In addition, the company offers RITUXAN for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL), rheumatoid arthritis, two forms of ANCA-associated vasculitis, and pemphigus vulgaris; RITUXAN HYCELA for non-Hodgkin's lymphoma and CLL; GAZYVA to treat CLL and follicular lymphoma; and OCREVUS for the treatment of primary progressive MS and relapsing MS, and other anti-CD20 therapies.
Further, it is involved in developing BIIB098, Opicinumab, and BIIB061 for MS and neuroimmunology; Aducanumab, Elenbecestat, BAN2401, BIIB092, BIIB076, and BIIB080 to treat Alzheimer's disease and dementia; BIIB092 and BIIB054 for treating Parkinson's disease and movement disorders; BIIB067, BIIB078, and BIIB110 to treat neuromuscular disorders; BIIB093, TMS-007, and Natalizumab to treat acute neurology; BIIB104 for treating neurocognitive disorders; BIIB074 and BIIB095 for pain; and Dapirolzumab pegol, BG00011, and BIIB059 for treating other diseases, which are under various stages of development.
The company offers products through its sales force and marketing groups. Biogen Inc. has collaboration agreements with Genentech, Inc., Eisai Co., Ltd., Alkermes Pharma Ireland Limited, Bristol-Myers Squibb Company, Acorda Therapeutics, Inc., AbbVie Inc., C4 Therapeutics, University of Pennsylvania, Applied Genetic Technologies Corporation, and others. The company was founded in 1978 and is headquartered in Cambridge, Massachusetts.
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IndustryBiotechnology
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No. of Employees7,800
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Website
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Jobs Posted445
